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NCT01753089 · ClinicalTrials.gov registry record · Phase 1

Dendritic Cell Activating Scaffold in Melanoma

A Phase 1 study of Melanoma, sponsored by Dana-Farber Cancer Institute.

Completed
Registry status
Phase 1
Development phase
23
Enrollment target
2
Study locations

NCT01753089 is a Phase 1 study of Melanoma that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 23 participants, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (97% lower). The trial reports 2 study locations across 1 state.

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The verdict

NCT01753089, a Phase 1 study of Melanoma, has completed, sponsored by Dana-Farber Cancer Institute.

COMPLETED
Registry status
Phase 1
Development phase
23 participants
Enrollment target
2
Study locations

Study Summary

This research study is a Phase I clinical trial. Phase I clinical trials test the safety of investigational melanoma vaccines. Phase I studies also try to define the appropriate dose of the investigational vaccine, in this case WDVAX, to use for further studies. "Investigational" means that the vaccine is still being studied and that research doctors are trying to find out more about it. It also means that the FDA has not yet approved WDVAX for any use in patients, including people with Melanoma. The purpose of this study is to determine if it is possible to make a vaccine against melanoma by using your own melanoma tumor cells and combining them with other proteins which activate the immune system. We hope that by combining the cells and the proteins in this way that the vaccine will cause your own immune system to react against your melanoma tumor cells. The purpose of this study is also to determine the safest way to give this vaccine with the least amount of side effects. Each vaccine will contain your own tumor cells which have been killed by a freezing and thawing process which destroys the cells but keeps the proteins from the melanoma cells. This is called a "tumor lysate" Your tumor lysate is combined with other proteins which activate the immune system. The other proteins are called GM-CSF and CpG. All of this is held together to form a "tablet" or "scaffold" which is about the size of a regular aspirin tablet. The material that holds the protein together is called PLGA. PLGA is the same material that doctors use for "dissolvable stitches" If you have ever had a problem with these types of stitches in the past, be sure to let your study doctor know about this.

Conditions Studied

Interventions

  • BIOLOGICAL WDVAX

Study Locations (2)

Massachusetts

  • Brigham and Women's Hospital - Boston
  • Dana-Farber Cancer Institute - Boston

Trial Details

FieldValue
Enrollment Target 23 participants
Start Date 2013-06
Est. Completion 2025-08-04
Phase Phase 1

Sponsor

Dana-Farber Cancer Institute

781 total trials

What the Registry Record Tells You About NCT01753089

The ClinicalTrials.gov registry entry for NCT01753089 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 23 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 706-participant average among 266 other Melanoma trials with a reported enrollment target (97% lower). The listed sponsor is Dana-Farber Cancer Institute, which has 781 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Melanoma appearing as the primary indexed condition, and to 1 intervention - of which WDVAX is the first listed.

NCT01753089 reports 2 study locations spanning 1 distinct geographic area - top geographies include Massachusetts.

Frequently Asked Questions

What is clinical trial NCT01753089 about?

NCT01753089 is a clinical study titled "Dendritic Cell Activating Scaffold in Melanoma". This research study is a Phase I clinical trial. Phase I clinical trials test the safety of investigational melanoma vaccines. Phase I studies also try to define the appropriate dose of the investigational vaccine, in this case WDVAX, to use for further studies. "Investigational" means that the vacc...

What is the current status of trial NCT01753089?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 23 participants. The study started on 2013-06. Estimated completion is 2025-08-04.

What conditions does trial NCT01753089 study?

This clinical trial studies the following conditions: Melanoma.

What interventions are being tested in trial NCT01753089?

The interventions under investigation include: WDVAX (BIOLOGICAL).

Who is sponsoring clinical trial NCT01753089?

This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01753089 being conducted?

This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.